FDA Device recall Z-1807-2023
ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1807-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
Reason
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Identifiers
| code_info | GTIN 00643169837812, Lot Serial numbers: CWJ604194S, CWJ604707S, CWJ604057S, CWJ602128S, CWJ604288S, CWJ602870S, CWJ60…GTIN 00643169837812, Lot Serial numbers: CWJ604194S, CWJ604707S, CWJ604057S, CWJ602128S, CWJ604288S, CWJ602870S, CWJ601914S, CWJ603587S, CWJ603802S, CWJ601000S, CWJ601001S, CWJ601158S, CWJ601706S, CWJ601799S, CWJ601845S, CWJ604343S, CWJ604387S, CWJ601910S, CWJ603379S, CWJ603449S, CWJ603454S, CWJ603109S, CWJ603385S, CWJ603717S, CWJ604036S, CWJ604043S, CWJ604092S, CWJ604118S, CWJ604397S, CWJ603165S, CWJ603501S, CWJ603684S, CWJ603685S, CWJ603693S, CWJ603831S, CWJ604218S, CWJ604314S, CWJ604338S, CWJ601875S, CWJ601903S, CWJ603686S, CWJ603836S, CWJ603869S, CWJ603875S, CWJ604377S, CWJ601894S, CWJ601905S, CWJ601909S, CWJ603429S, CWJ603660S, CWJ603060S, CWJ603731S, CWJ603760S, CWJ604336S, CWJ604355S, CWJ603859S, CWJ603697S, CWJ603700S, CWJ603849S, CWJ604337S, CWJ603687S, CWJ603695S, CWJ601906S, CWJ603445S, CWJ603873S, CWJ604179S, CWJ603842S, CWJ604042S, CWJ604094S, CWJ604339S, CWJ604358S, CWJ604117S, CWJ601891S, CWJ602956S, CWJ603275S, CWJ604684S, CWJ603881S, CWJ603884S, CWJ603939S, CWJ603957S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1807-2023%22
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